Biological indicator system classification under MDR

#1
Hi:

I've read discussions in this forum regarding biological indicator classification, and it seems the jury is still out whether it's considered an accessory to the sterilizer device (which I understand is a Class IIb device). The argument for treating a BI as an accessory is the sterilizer manufacturer uses it to validate their sterilizer and thus the BI is included in their technical file. My question is, since most sterilizer manufacturer don't make their own BIs, does that mean the BI manufacturer can only market their product if the sterilizer manufacturer agrees to incorporate the BI in their technical file? Obviously this is not the case since BIs have always been marketed as standalone products. So my next question is, being an accessory according to the new MDR rules, does the BI manufacturer have to validate their BI with all compatible sterilizers so the latter can claim them as accessories?

What about the BI incubator/reader that has a software component? How should they be classified under MDR?
 
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#2
koferong,

as of now this current BSI whitepaper confirms your note on the unclear regulatory status of BIs under MDR, but because of a different argument - quote from p. 23:
Consequently, sterilization indicators that were previously outside the Directive can now be considered accessories to the sterilizing equipment (now considered a device) and are thus covered by the MDR. However, the exclusion in the scope of the Regulation for products that contain or consist of living microorganisms introduces a situation where biological indicators for sterilization could be considered excluded from the Regulation, but chemical indicators for sterilization considered as accessories.
Typically, BIs complying with the ISO ISO 11138 series, have no interdependence of sterilisation equipment /process and BI brand: after all, the manufacturer is typically only responsible to provide equipment that is capable of being operated in the desired parameter range. It then depends on the specific (custom) sterilisation process whether a defined sterility assurance level can be reproducibly met within validated process parameter settings, irrespective of used BI brand.

HTH,
 
#3
So the status of biological indicators is in limbo within the MDR? By being "excluded from the Regulation", does it mean BIs are not regulated in the EC? Does that make any sense to anyone? What about the BI incubator/reader that has a software component? Are they also excluded?
 
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